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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. GORILLA PLATING SYSTEM; MTP PLATE
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PARAGON 28, INC. GORILLA PLATING SYSTEM; MTP PLATE Back to Search Results
Device Problem Unstable (1667)
Patient Problem Failure of Implant (1924)
Event Date 10/28/2021
Event Type  Injury  
Manufacturer Narrative
Limited information was received from the initiator in this event.The device remains implanted in patient, therefore, was not returned for evaluation.No patient impact has been reported.Clinical review of the radiographic image was completed and confirms the plate is broken over the joint, at the precision guide holes.Device history records were not reviewed because the part and lot number were not reported.
 
Event Description
Mtp plate broke after 40 days of non-bearing.It was reported that the patient does not want a re-operation to remove the plate.
 
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Brand Name
GORILLA PLATING SYSTEM
Type of Device
MTP PLATE
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7207165439
MDR Report Key12872448
MDR Text Key284917661
Report Number3008650117-2021-00133
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K140397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
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